EvaluationsPhase 4NCT03734042
PRP Intrauterine Infusion in Thawed Embryo Cycles
A Phase 4 study testing Platelet rich plasma intrauterine infusion and Normal saline in people with Evaluations, run by Tanta University at 1 site in Egypt.
Trial summary
All patients prepared to thawed embryo transfer were classified into 2 groups one group will receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive platelet rich plasma (PRP) infusion Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Evaluations
- What is being tested?
- Platelet rich plasma intrauterine infusion and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 31 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 20-35 years
- Patients with previous implantation failure
- Patients with thin endometrium<7 mm
Who cannot join
- Patients older than 40 years
- Patients with fresh embryo transfer
- Patients with abnormal uterine cavity septate, or bicornuate uterus
- Patients with abnormal male factor or tubal factor
- Patients with abnormal embryos grade B or C.
- Patients with immunological disorders as thyroidits or systemic lupus or rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Infusion of Platelet-rich Plasma Infusion Before Thawed Embryo Transfer in Repeated Implantation Failure: A Randomized Controlled Study
All patients prepared to thawed embryo transfer were classified into 2 groups one group will receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive platelet rich plasma (PRP) infusion
Read the detailed description
Patients candidates for Thawed embryo transfer with Repeated implantation failure were recruited from 3 centers and classified into 2 groups:
Group I: Will receive platelet rich plasma (PRP) intrauterine infusion at day 11
Group II: Not receiving platelet rich plasma (PRP)
- Conditions
- Evaluations
- Being tested
- Platelet rich plasma intrauterine infusion, Normal saline
- Keywords
- Platelet rich plasma, Intrauterine infusion, Thawed embryos, IVF/ICSI cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma intrauterine infusionBiological
platelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11
Normal salineBiological
Intrauterine infusion of normal saline at day 11
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | These patients will receive platelet rich plasma intrauterine infusion at day 11 Receives: Biological: Platelet rich plasma intrauterine infusion |
| Control group | Placebo comparator | These patients will receive intrauterine normal saline infusion at day 11 Receives: Biological: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
The increase in endometrial thickness at day of ET
Measured: 8 days
Pregnancy rate
Number of cases who got pregnant
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Dec 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluationsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups parallel
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734042
- Sponsor's protocol ID
- PRPF
- Status last verified
- Nov 2021
- First submitted
- 6 Nov 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Infusion of Platelet-rich Plasma Infusion Before Thawed Embryo Transfer in Repeated Implantation Failure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03734042
- Acronym / sponsor ID
- PRPF
- Conditions
- Evaluations
- Keywords
- Platelet rich plasma, Intrauterine infusion, Thawed embryos, IVF/ICSI cycles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All patients prepared to thawed embryo transfer were classified into 2 groups one group will receive platelet rich plasma (PRP) infusion intrauterine and the other group will not receive platelet rich plasma (PRP) infusion
Detailed description
Patients candidates for Thawed embryo transfer with Repeated implantation failure were recruited from 3 centers and classified into 2 groups:
Group I: Will receive platelet rich plasma (PRP) intrauterine infusion at day 11
Group II: Not receiving platelet rich plasma (PRP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups parallel
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: Platelet rich plasma intrauterine infusionThese patients will receive platelet rich plasma intrauterine infusion at day 11 |
| Control group | Placebo comparator | Biological: Normal salineThese patients will receive intrauterine normal saline infusion at day 11 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age 20-35 years
- Patients with previous implantation failure
- Patients with thin endometrium<7 mm
Key exclusion criteria (6 listed)
- Patients older than 40 years
- Patients with fresh embryo transfer
- Patients with abnormal uterine cavity septate, or bicornuate uterus
- Patients with abnormal male factor or tubal factor
- Patients with abnormal embryos grade B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich plasma intrauterine infusionplatelet rich plasma will be prepared, activated then infused by Intrauterine insemination catheter intrauterine at day 11 | Biological | PRP group |
| Normal salineIntrauterine infusion of normal saline at day 11 | Biological | Control group |
Primary outcome
Endometrial thickness
Time frame: 8 days
The increase in endometrial thickness at day of ET
Pregnancy rate
Time frame: 15 days
Number of cases who got pregnant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No. not allowed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet rich plasma intrauterine infusion and Normal saline in people with Evaluations, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.